• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

EuroPCR Roundup: Bioresorbable stents show promise, but metallic drug-eluting stents remain standard

May 22, 2017 By Sarah Faulkner

Amaranth Medical highlights 9-month follow-up data for Aptitude sirolimus-eluting bioresorbable scaffold

Amaranth MedicalAmaranth Medical touted 9-month follow-up data today from the Renascent-II trial, which evaluated the company’s Aptitude sirolimus-eluting bioresorbable scaffold.

Aptitude is a poly-L-lactide-based, sirolimus-eluting bioresorbable scaffold that features a strut thickness of 115 microns. The 60-patient trial had a 98.3% device success rate, high scaffold stability and a 97% level of strut coverage at 9 months.

The company also said that no instances of thrombosis or binary restenosis were reported in this patient population.

Amaranth submitted an application for CE Mark approval of its Aptitude scaffold in the December last year and said that it expects to win approval in the 2nd half of 2017. Based on data from the Renascent-II trial, the company plans to start discussions with partners and sources of financing to continue developing its tech for coronary, peripheral and neurological indications.

Amaranth added that it is planning initial commercial preparations for the 1st sub-100 micron bioresorbable scaffold, Magnitude.

“The BRS field is navigating turbulent waters right now; however, I continue to believe that complete scaffold absorption brings additional value to the patient by decreasing progressive late lumen loss and expanding the re-intervention options in comparison to metallic DES,” co-principal investigator Juan Granada said in prepared remarks. “The technical and clinical performance of the thin-walled Aptitude BRS has been successfully evaluated in a multi-center clinical trial. I am looking forward to seeing this device used in real-world cases.”

“Clinical outcomes at 9-months for the patients in the Renascent-II trial have been excellent, displaying a safety and efficacy profile compared to metallic DES. We hope that long-term data continue to confirm the structural stability and safety of the device and add momentum to the field again,” co-principal investigator Dr. Antonio Colombo added.

NEXT: Boston Scientific’s Lotus beats Medtronic’s CoreValve in head-to-head study

Pages: Page 1 Page 2 Page 3 Page 4 Page 5 Page 6 Page 7 Page 8

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Featured, Pharmaceuticals, Vascular Tagged With: Abbott Laboratories, amaranthmedical, Medtronic, Micell Technologies, Reva Medical, sveltemedicalsystem, xience

IN CASE YOU MISSED IT

  • Insulet hires new chief HR officer from J&J
  • Breakthrough T1D, Mattel debut Barbie doll with type 1 diabetes
  • Medtronic Diabetes names CFO with consumer experience ahead of separation
  • Diabeloop launches insulin delivery algorithm in Germany
  • GlucoModicum has positive data for needle-free CGM

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing + Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy | RSS